NCT01433146 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Kohno Y, Maruyama M, Matsuoka Y, Matsushita T, Koeda M, Matsushima E
Relationship of psychological characteristics and self-efficacy in gastrointestinal cancer survivors. Psychooncology. 2010 Jan;19(1):71-6. doi: 10.1002/pon.1531.
Nan KJ, Wei YC, Zhou FL, Li CL, Sui CG, Hui LY, Gao CG
Effects of depression on parameters of cell-mediated immunity in patients with digestive tract cancers. World J Gastroenterol. 2004 Jan 15;10(2):268-72.

Effect of Temperament, Anxiety and Depression on Immuninity in Colorectal Cancer Patients.

Clinical trial NCT01433146 - References